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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012274-08
Device Problems Detachment Of Device Component (1104); Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Visual inspection was performed on the returned device. The shaft separation and kink were confirmed. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a lesion in the posterior descending artery with mild tortuosity and mild calcification. A 3x8mm trek rx balloon dilatation catheter (bdc) was inserted into an unspecified guide catheter, the mid shaft kinked. The physician withdrew the bdc and the mid shaft separated. Reportedly there was no resistance noted during advancement or withdrawal. Both pieces were simply withdrawn from the guide catheter. An unspecified balloon was used to continue the procedure. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key5975200
MDR Text Key55799417
Report Number2024168-2016-06355
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue Number1012274-08
Device Lot Number60415G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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